17 days old

Process Development Associate Scientist

Amgen
Cambridge, MA 02138
  • Job Code
    119148738
Amgen

Job ID: R-96629
Location: Cambridge, MA, US 02139

Amgen is currently seeking a Process Development Associate Scientist for our Pivotal Drug Product Technologies Group in Cambridge, MA. This group is responsible for late stage drug product formulation and fill/finish process development for large molecule modalities (e.g. monoclonal antibodies, bispecific T-cell engagers (BiTEs) and fusion proteins). Working closely with a team of scientists and engineers, the successful candidate will apply scientific and engineering principles to advance the technical aspects of Amgen's drug product and process development. Additionally, the position will have focus in the application of data science and statistics to inform decisions throughout drug product development.

Responsibilities include:
  • Participate in the design and planning of laboratory studies related to formulation and fill/finish process development by applying basic science/engineering skills, first principles modeling, and prior knowledge
  • Execute and document laboratory studies with a high degree of technical rigor
  • Evaluate product and process performance through analytical testing (e.g. U/HPLC, particle analysis, moisture content) and perform data analysis using statistical analysis software (e.g. JMP, SAS, etc.)
  • Apply advanced digital tools to automate data structuring, analyze large and diverse datasets and build intuitive visualizations.
  • Manage multiple activities in parallel to drive project plans to completion, meeting project timelines and milestones
  • Author and contribute to technical reports and presentations to management on technical challenges, proposed solutions and results
  • Participate in team meetings by sharing study designs, results and technical challenges
  • Ability to travel domestically and internationally up to 10% of the time


Basic Qualifications
  • Master's degree and 2 years of scientific experience
  • OR
  • Bachelor's degree and 4 years of scientific experience


Preferred Qualifications
  • Master's degree in Chemical Engineering, Biomedical Engineering, Biochemistry, Biotechnology, Pharmaceutics or related discipline
  • 4+ years of industry experience in pharmaceuticals/biotechnology or related field
  • Knowledge of/hands-on experience with formulation and commercial process development for liquid and lyophilized drug products
  • Experience with unit operation (i.e. filling, filtration, mixing, etc.) specific scale down model development, characterization, and scale-up
  • Understanding of physical/chemical stability of proteins and how process related stress impacts product quality, specifically, the impact of freezing and drying to short- and long-term stability
  • Strong problem solving and effective cross-functional communication skills
  • Experience with coding/scripting for automated data analysis and modeling
  • Experience with data visualization tools or packages, such as Tableau or Spotfire


Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

PI119148738

<b>Amgen</b><br/><br/><b>Job ID: </b>R-96629<br/><b>Location: </b>Cambridge, MA, US 02139<br/><br/>Amgen is currently seeking a Process Development Associate Scientist for our Pivotal Drug Product Technologies Group in Cambridge, MA. This group is responsible for late stage drug product formulation and fill/finish process development for large molecule modalities (e.g. monoclonal antibodies, bispecific T-cell engagers (BiTEs) and fusion proteins). Working closely with a team of scientists and engineers, the successful candidate will apply scientific and engineering principles to advance the technical aspects of Amgen's drug product and process development. Additionally, the position will have focus in the application of data science and statistics to inform decisions throughout drug product development.<br><br>Responsibilities include:<br><ul><li>Participate in the design and planning of laboratory studies related to formulation and fill/finish process development by applying basic science/engineering skills, first principles modeling, and prior knowledge</li><li>Execute and document laboratory studies with a high degree of technical rigor</li><li>Evaluate product and process performance through analytical testing (e.g. U/HPLC, particle analysis, moisture content) and perform data analysis using statistical analysis software (e.g. JMP, SAS, etc.)</li><li>Apply advanced digital tools to automate data structuring, analyze large and diverse datasets and build intuitive visualizations.</li><li>Manage multiple activities in parallel to drive project plans to completion, meeting project timelines and milestones</li><li>Author and contribute to technical reports and presentations to management on technical challenges, proposed solutions and results</li><li>Participate in team meetings by sharing study designs, results and technical challenges</li><li>Ability to travel domestically and internationally up to 10% of the time</li></ul><br><br><b>Basic Qualifications</b><br><ul><li>Master's degree and 2 years of scientific experience</li><li>OR</li><li>Bachelor's degree and 4 years of scientific experience</li></ul><br><br><b>Preferred Qualifications</b><br><ul><li>Master's degree in Chemical Engineering, Biomedical Engineering, Biochemistry, Biotechnology, Pharmaceutics or related discipline</li><li>4+ years of industry experience in pharmaceuticals/biotechnology or related field</li><li>Knowledge of/hands-on experience with formulation and commercial process development for liquid and lyophilized drug products</li><li>Experience with unit operation (i.e. filling, filtration, mixing, etc.) specific scale down model development, characterization, and scale-up</li><li>Understanding of physical/chemical stability of proteins and how process related stress impacts product quality, specifically, the impact of freezing and drying to short- and long-term stability</li><li>Strong problem solving and effective cross-functional communication skills</li><li>Experience with coding/scripting for automated data analysis and modeling</li><li>Experience with data visualization tools or packages, such as Tableau or Spotfire</li></ul><br> <br> Join Us <br> <br> If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. <br> <br> Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. <br> <br> As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. <br> <br> Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.<br/><br/> <img src="https://analytics.click2apply.net/v/k54j6BCNON2zt7A8i4BJg"> <p>PI119148738</p>

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Posted: 2020-03-19 Expires: 2020-04-19

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Process Development Associate Scientist

Amgen
Cambridge, MA 02138

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